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PittPRO Device Information

Guidance for Completing the Device Section for PittPRO

Study Scope page

If the study will evaluate the safety or effectiveness of a device, this question must be answered “Yes.”  Answering “Yes” will display an additional page later in the application so appropriate information can be included for review.

If the study will use a device but not evaluate it for safety or effectiveness, this question should be answered "No".  An example would be a study that uses an approved surgical device for adults in a pediatric population, but the study is only intended to evaluate a drug designed to accelerate healing after surgery.

Device page

  • List each device in the study that will be evaluated for safety or effectiveness: Use the “Add” button to enter the information related to the device being used in the study.  If there is more than one device in the study, use the “Add” button to create separate entries for each device.
     
    • Select the device - Perform a search by typing the first letters of the device in the field. If the device is not contained in the drop-down menu, type the name of the device in the appropriate field.
       
    • Purpose of their use - Provide information related to the reason the device is being evaluated in the study.
       
    • Device exemptions applicable to this device - To complete this section, two factors must be known/determined. 1) the risk level associated with the device and 2) whether the device has any FDA-approved indication.

 

Applicable Device Exemptions 

Explanation 

IDE number

An IDE is required to evaluate a significant risk device that is not being used according to its legally marketed product label or has no FDA approved indication at all and has potential for serious risk to the health, safety, or welfare of a subject. Significant risk devices may include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigating or treating disease or in preventing impairment to human health.

Claim of abbreviated IDE (nonsignificant risk device)

Select this choice if the study will evaluate a non-significant risk device and it is not being used according to its legally marketed product label. Non-significant risk devices are subject to some of the IDE regulations, and are considered abbreviated IDEs. In this case, no FDA submission is required. However, the sponsor must comply with the abbreviated IDE requirements under 21 CFR 812.2 (b).

Exempt from IDE requirements

If the study will evaluate a device and it is being used according to its legally marketed product label, it is exempt from IDE requirements. Other devices that are exempted from IDE requirements include:

  • diagnostic device if it complies with the labeling requirements in 21 CFR 809.10(c) and if the testing is noninvasive; does not require an invasive sampling procedure that presents significant risk; does not by design or intention introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure.

  • device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.

  • custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.

Learn more at FDA IDE Exempt Investigations. 

 

  • Upload the manufacturer's description of device/FDA-approved product labeling/product instructions (all that are available and applicable). Documents should include items such as the FDA-approved device label, the manufacturer’s description of device, and device instructions.

If applicable, identify each investigational device exemption (IDE) number:

  • Use the “Add” button to enter information related to the IDE number and sponsor.
     
    • Use the “Add” button to enter information related to the IDE number and sponsor.
       
    • IDE number — enter the IDE number as listed on the cover page of the protocol document or the FDA Acknowledgement letter.
       
    • Who will serve as the Sponsor of this IDE?

Sponsor

Explanation

Commercial/Industry Sponsor

Select Commercial/Industry Sponsor if a corporate company such as a drug manufacturer or CRO will act as sponsor of the IDE Application

University of Pittsburgh/UPMC Investigator

Select University of Pittsburgh/UPMC Investigator if a University faculty member or UPMC clinician will act as sponsor of the IDE Application

Other

Select Other if the IDE sponsor is not commercial/industry or a Pitt/UPMC investigator. If Other, identify the name of IDE holder and their institution.
  1. Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. In this instance, sponsor does not mean the source of financial support. It is important to select the correct choice as an incorrect choice will result in the study not going to the appropriate Ancillary Reviewers.
  2. If the clinical trial is externally sponsored, the clinical trial documents provided by the sponsor should clearly indicate whether it is being conducted under an IDE.

Attach files ​

  • Attachments may include justification of risk determination, FDA correspondence and if the holder of the IDE is a University of Pittsburgh based, sponsor-investigator, attach both the FDA acknowledgement letter and approval letter.

Describe your plan to manage devices so that they will be used only on subjects and be used only by authorized investigators:​

  • ​Address how the device will be secured: where will it be stored (e.g., locked cabinet in the OR) and how access will provided only to those authorized investigators (e.g., process for distribution).

version 9/11/2019